Institutional Compliance Institutional Compliance & Ethics Council:& Ethics Council:COI WorkgroupCOI Workgroup

October 24, 2007October 24, 2007

Chair:Chair:

Camille A. McWhirter, J.D. Camille A. McWhirter, J.D. USF Health Office of Research USF Health Office of Research Office of Research ComplianceOffice of Research Compliance

Institutional ObjectiveInstitutional Objective

To provide an infrastructure that facilitates To provide an infrastructure that facilitates compliance with internal and external compliance with internal and external laws, regulations, policies, and procedures laws, regulations, policies, and procedures and targets industry standards and best and targets industry standards and best practices in the review and management practices in the review and management of conflicts of interest in all areas of of conflicts of interest in all areas of University operations.University operations.

COI Workgroup Objectives COI Workgroup Objectives

Level I. Organization and Accountability of Individual COI Level I. Organization and Accountability of Individual COI Units/ProgramsUnits/Programs

A.A. Identify individual COI “units” or “programs” Identify individual COI “units” or “programs” B.B. Recommend assignments of individual responsibility Recommend assignments of individual responsibility

for COI oversight in various areas (i.e., shared for COI oversight in various areas (i.e., shared responsibility is no responsibility)responsibility is no responsibility)

C.C. Evaluate each existing unit or program in relation to Evaluate each existing unit or program in relation to COI requirements, industry standards and best COI requirements, industry standards and best practicespractices

D.D. Make recommendations to address specific concerns Make recommendations to address specific concerns arising from the program evaluationarising from the program evaluation

COI Workgroup Objectives (con’t)COI Workgroup Objectives (con’t)

Level II. Integration and Coordination of COI ActivitiesLevel II. Integration and Coordination of COI Activities

Implement a comprehensive website for University Implement a comprehensive website for University employees to describe the diverse areas of COI and employees to describe the diverse areas of COI and the policies, processes, training opportunities and the policies, processes, training opportunities and contact info applicable to each COI Unit/Program.contact info applicable to each COI Unit/Program.

Develop and coordinate consistent messages at Develop and coordinate consistent messages at employee orientation, end user, and other training employee orientation, end user, and other training programs as appropriate across programs as appropriate across the various the various classification levels. classification levels.

Integrate COI disclosure, review and management Integrate COI disclosure, review and management processes where possible to reduce institutional and processes where possible to reduce institutional and employee and institution “paperwork” and to avoid employee and institution “paperwork” and to avoid duplication of effortduplication of effort

MembershipMembership

Camille McWhirter-Chair (Institutional Conflicts of Interest/USF & Camille McWhirter-Chair (Institutional Conflicts of Interest/USF & Health)Health)

Dwayne Smith-Vice-Chair (Outside Activity & Nepotism-Faculty/USF Dwayne Smith-Vice-Chair (Outside Activity & Nepotism-Faculty/USF & Vendor Interactions--Main Campus)& Vendor Interactions--Main Campus)

Michael Stephens (OA & Nepotism-Staff/USF & Health)Michael Stephens (OA & Nepotism-Staff/USF & Health) Tom DiBella (Employees as Vendors & Purchasing Agents/USF)Tom DiBella (Employees as Vendors & Purchasing Agents/USF) Olga Joanow (OA & Nepotism-Faculty/Health)Olga Joanow (OA & Nepotism-Faculty/Health) Patsy Bickel (Vendor Interactions--Medical Center/Health) Patsy Bickel (Vendor Interactions--Medical Center/Health) Liz O’Connell (COI in Research-Disclosure & Reporting/USF)Liz O’Connell (COI in Research-Disclosure & Reporting/USF) Vinita Witanachchi (COI in Research-Review & Monitoring/USF & Vinita Witanachchi (COI in Research-Review & Monitoring/USF &

Health))Health)) Joan Bailey (Financial Aid & Lender Relationships/USF)Joan Bailey (Financial Aid & Lender Relationships/USF) Valerie McDevitt (Tech Transfer Issues/USF)Valerie McDevitt (Tech Transfer Issues/USF) Theresa Chisolm (Faculty Rep/USF) Theresa Chisolm (Faculty Rep/USF) Bill Marshall (Faculty Rep/Health)Bill Marshall (Faculty Rep/Health)

Individual COI UnitsIndividual COI Units

Financial Interests in Research/Disclosure Financial Interests in Research/Disclosure & Reporting & Reporting Responsible Person: Liz O’ConnellResponsible Person: Liz O’Connell

Financial Interests in Research/Review & Financial Interests in Research/Review & ManagementManagement Responsible Person: Vinita WitanachchiResponsible Person: Vinita Witanachchi

Vendor Interactions at the Medical CenterVendor Interactions at the Medical Center Responsible Person: Patsy BickelResponsible Person: Patsy Bickel

Individual COI Units (con’t)Individual COI Units (con’t)

Employee as Purchasing Agent or VendorEmployee as Purchasing Agent or Vendor Responsible Party: Tom DiBellaResponsible Party: Tom DiBella

Financial or Business Relationships in Financial or Business Relationships in Technology TransferTechnology Transfer Responsible Party: Valerie McDevittResponsible Party: Valerie McDevitt

Outside Activity & Nepotism: USF FacultyOutside Activity & Nepotism: USF Faculty Responsible Party: Dwayne SmithResponsible Party: Dwayne Smith

Vendor Interactions on Main CampusVendor Interactions on Main Campus Responsible Party: Dwayne SmithResponsible Party: Dwayne Smith

Individual COI Units (con’t)Individual COI Units (con’t)

Outside Activity & Nepotism: Health FacultyOutside Activity & Nepotism: Health Faculty Responsible Party: Olga JoanowResponsible Party: Olga Joanow

Outside Activity & Nepotism: USF & Health StaffOutside Activity & Nepotism: USF & Health Staff Responsible Party: Michael StephensResponsible Party: Michael Stephens

Institutional Conflicts of InterestInstitutional Conflicts of Interest Responsible Party: Camille McWhirterResponsible Party: Camille McWhirter

Financial AidFinancial Aid Lender RelationshipsLender Relationships Responsible Party: Joan BaileyResponsible Party: Joan Bailey

Faculty RepresentativesFaculty Representatives

Faculty Representative: HealthFaculty Representative: Health Bill MarshallBill Marshall

Faculty Representative: USFFaculty Representative: USF Theresa ChisolmTheresa Chisolm

COI Workgroup Objectives COI Workgroup Objectives

Level I. Organization and Accountability of Individual COI Level I. Organization and Accountability of Individual COI Units/ProgramsUnits/Programs

Identify individual COI “units” or “programs” Identify individual COI “units” or “programs” Recommend assignments of individual responsibility Recommend assignments of individual responsibility

for COI oversight in various areas (i.e., shared for COI oversight in various areas (i.e., shared responsibility is no responsibility)responsibility is no responsibility)

C.C. Evaluate each existing unit or program in relation to Evaluate each existing unit or program in relation to COI requirements, industry standards and best COI requirements, industry standards and best practicespractices

D.D. Make recommendations to address specific concerns Make recommendations to address specific concerns arising from the program evaluationarising from the program evaluation

Level 1 Objective : Organization and Level 1 Objective : Organization and Accountability of Individual COI UnitsAccountability of Individual COI Units

Part I.Part I.

Describe the ProgramDescribe the Program

Part II. Part II.

Identify Program Effectiveness Targets: Identify Program Effectiveness Targets: Regulatory/Standards/Best PracticesRegulatory/Standards/Best Practices

Part III. [For later]Part III. [For later]

Evaluate Effectiveness Of Existing COI Processes & Evaluate Effectiveness Of Existing COI Processes & Identify GapsIdentify Gaps

Part I: Describe the ProgramPart I: Describe the ProgramA.A. NeedNeed: A statement of need describes the : A statement of need describes the

problem or opportunity that the program problem or opportunity that the program addresses and implies how the program will addresses and implies how the program will respond. respond.

B.B. Expected effectsExpected effects:: Descriptions of expected Descriptions of expected effects convey what the program must effects convey what the program must accomplish to be considered successful. accomplish to be considered successful.

C.C. Primary RisksPrimary Risks: Identify the primary risks : Identify the primary risks associated with an ineffective program. associated with an ineffective program.

D.D. ActivitiesActivities:: Describe specific steps, strategies, Describe specific steps, strategies, or actions in a logical sequence. This or actions in a logical sequence. This demonstrates how each program activity relates demonstrates how each program activity relates to another.to another.

Part I: Describe the Program (con’t)Part I: Describe the Program (con’t)

E.E. ResourcesResources:: Resources include the time, talent, Resources include the time, talent, technology, information, money, and other assets technology, information, money, and other assets available to conduct program activities.available to conduct program activities.

F.F. Stage of developmentStage of development::

1.1. Planning. Planning. During planning, program activities are untested, During planning, program activities are untested, and the goal of evaluation is to refine plans.and the goal of evaluation is to refine plans.

2.2. Implementation. Implementation. During implementation, program activities are During implementation, program activities are being field-tested and modified; the goal of evaluation is to being field-tested and modified; the goal of evaluation is to characterize real, as opposed to ideal, program activities and characterize real, as opposed to ideal, program activities and to improve operations, perhaps by revising plans. to improve operations, perhaps by revising plans.

3.3. EffectsEffects. The goal of evaluation is to identify and account for . The goal of evaluation is to identify and account for both intended and unintended effects. both intended and unintended effects.

Part I: Describe the Program (con’t)Part I: Describe the Program (con’t)

G.G. ContextContext:: Descriptions of the program’s context (e.g., Descriptions of the program’s context (e.g., history, geography, politics, social and economic history, geography, politics, social and economic conditions, and efforts of related departments) within conditions, and efforts of related departments) within which the program operates. Understanding these which the program operates. Understanding these environmental influences is required to design a environmental influences is required to design a context-sensitive evaluation. context-sensitive evaluation.

H.H. (Optional) (Optional) Visual descriptionVisual description: : Demonstrate visually Demonstrate visually how issues are brought to the program and resolved how issues are brought to the program and resolved (or not resolved as the case may be In other words, (or not resolved as the case may be In other words, use a flow chart, map, or table to portray the sequence use a flow chart, map, or table to portray the sequence of steps leading to program results.of steps leading to program results.

Part II: Identify Program Part II: Identify Program Effectiveness TargetsEffectiveness Targets

A.A. Regulatory requirements targetsRegulatory requirements targets• What rules apply (laws, regulations, agency What rules apply (laws, regulations, agency

policies, University policies)policies, University policies)• To whom (staff, faculty, students, researchers, To whom (staff, faculty, students, researchers,

sub grantees, etc.)sub grantees, etc.)• To what functions (procurement, research, To what functions (procurement, research,

employment, etc.)employment, etc.)

B.B. Industry standard targetsIndustry standard targets

C.C. Best practices targetsBest practices targets

Part III: Evaluate Program Part III: Evaluate Program EffectivenessEffectiveness

A. Compare University policies/practices to A. Compare University policies/practices to

• regulatory requirements regulatory requirements • industry standards/guidanceindustry standards/guidance• best practices at other institutionsbest practices at other institutions

B. Identify “gaps” or deficiencies in existing B. Identify “gaps” or deficiencies in existing policies, processes or programs that inhibit policies, processes or programs that inhibit program effectiveness program effectiveness

Sample Program Evaluation: Sample Program Evaluation: Parts I &IIParts I &II

COI Program:COI Program:

Financial Interests in Research/Review & Financial Interests in Research/Review & Management Management

Responsible PartyResponsible Party: Vinita Witanachchi: Vinita Witanachchi

Sample Program DescriptionSample Program Description

I.I. NeedNeed: This program operates a system for the : This program operates a system for the review and management of disclosures of review and management of disclosures of financial interests relating to research.financial interests relating to research.

II.II. Expected EffectsExpected Effects: To be successful the : To be successful the program must provide forprogram must provide for

A.A. Knowledgeable review of disclosuresKnowledgeable review of disclosuresB.B. Process for development of appropriate management Process for development of appropriate management

planplanC.C. Process for communicating results of review to Process for communicating results of review to

investigator, DSR, IRBinvestigator, DSR, IRBD.D. Process for monitoring compliance with approved Process for monitoring compliance with approved

management planmanagement plan

Sample Program Description (con’t)Sample Program Description (con’t)

III.III. Primary RisksPrimary Risks

A.A. Loss of federal funding from NIH and NSFLoss of federal funding from NIH and NSFB.B. IRB accreditation at riskIRB accreditation at riskC.C. Loss of public trust in research, loss of Loss of public trust in research, loss of

donors donors D.D. Sponsors want assurance that institutions Sponsors want assurance that institutions

are managing COI of investigators; are managing COI of investigators; otherwise could be very costly to sponsors; otherwise could be very costly to sponsors; won’t work with institutions whose COI won’t work with institutions whose COI review and management program is review and management program is deficientdeficient

Sample Program Description (con’t)Sample Program Description (con’t)

III.III. ActivitiesActivities

A.A. Receive disclosureReceive disclosureB.B. Review of disclosure by administrative officialReview of disclosure by administrative officialC.C. Determination of necessity for Committee Determination of necessity for Committee

review/management planreview/management planD.D. (If required) Develop management plan with investigator (If required) Develop management plan with investigator E.E. (If required) Committee review(If required) Committee reviewF.F. Action on disclosureAction on disclosureG.G. Notification of action on disclosure to:Notification of action on disclosure to:

1.1. InvestigatorInvestigator2.2. DSR (if sponsored)DSR (if sponsored)3.3. IRB (if human subjects involved)IRB (if human subjects involved)

H.H. MonitoringMonitoring

Sample Program Description (con’t)Sample Program Description (con’t)

IV.IV. ResourcesResources

A.A. Knowledgeable Administrative OfficialKnowledgeable Administrative Official B.B. Committee (5-9 members)Committee (5-9 members)C.C. Interactive DatabaseInteractive DatabaseD.D. Standard office resources (computer, copier, etc.)Standard office resources (computer, copier, etc.)

V.V. Stage of developmentStage of development

A.A. EffectsEffects. The goal of this program evaluation is to . The goal of this program evaluation is to identify and account for both intended and identify and account for both intended and unintended effects. unintended effects.

Sample Program Description (con’t)Sample Program Description (con’t)

VI.VI. ContextContext::

This program originated in the mid 1990’s as a result This program originated in the mid 1990’s as a result of a DHHS/NIH and NSF policy on objectivity in of a DHHS/NIH and NSF policy on objectivity in research. research.

The program was further refined in 2003 as a result The program was further refined in 2003 as a result of attention to this issue and guidance issued for of attention to this issue and guidance issued for academic medical centers. The outcome was the academic medical centers. The outcome was the formation of a policy committee at USF Health and formation of a policy committee at USF Health and ultimately the development of a USF Health specific ultimately the development of a USF Health specific policy and Committee. policy and Committee.

Sample Program Description (con’t)Sample Program Description (con’t)

IV.IV. ContextContext (con’t): (con’t):

The original USF Committee then elected to refer The original USF Committee then elected to refer medical issues to the USF Health Committee based on medical issues to the USF Health Committee based on its expertise in medical research issues. Finally, a its expertise in medical research issues. Finally, a decision was made in association with application of decision was made in association with application of our IRB for accreditation (2004) to refer all human our IRB for accreditation (2004) to refer all human subjects research through the USF Health program.subjects research through the USF Health program.

There is currently an agenda within the USF Office of There is currently an agenda within the USF Office of Research to consolidate the two programs under the Research to consolidate the two programs under the USF Division of Research Integrity & Compliance. USF Division of Research Integrity & Compliance.

Sample Program Description (con’t)Sample Program Description (con’t)

V.V. Visual Description

Is this research involving human subjects?

START

Do you have a financial interest or external

commitment that relates to or could have a direct impact on current or

proposed research?

Submit form to USF Health Conflict of

Interest (COI) Administrator

(Camille McWhirter MDC 2)

USF Health COI Committee or Administrative Review

Notify investigator of COI determination and forward approval

memo and management plan (if any) to Institutional Review Board (IRB)

and DSR, if applicable

STOP

Financial Interest or External Commitment means any compensation which is paid or given to the you (or your spouse or dependent children) directly, indirectly, or in trust by any other means; or an advisory, ownership or any other interest or relationship in any entity or person related to the research.

CONFLICT OF INTEREST IN RESEARCH: DISCLOSURE AND REVIEW PROCESS

Human subject means a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.

Are you affiliated with USF Health?

YES

Complete a Financial Relationships Disclosure Form

(FRDF)

NO

YES

Submit form to USF Conflict of Interest in

Research (CoIRC) Committee

(Vinita Witanachchi MDC 35)

YES

Are you a faculty member in the College of Medicine?

USF CoIRC or Administrative Review

Is the research sponsored?

NO

Submit form to Division of Sponsored Research (Liz O’Connell ADM 200)

YES

YES

Submit form to Division of Sponsored Research

(Liz O’Connell ADM 200)

YES

NO

STOP

Financial RelationshipsDisclosure Form

Notify investigator of COI determination and forward approval

memo and management plan (if any) to DSR, if applicable

Is the research sponsored?

YES

Are you affiliated with USF Health? NO

YES

NO

STOP. This process does not

apply to you. NO

NO

NO

Is the research sponsored?

Sample Program Effectiveness Sample Program Effectiveness TargetsTargets

I.I. Regulatory RequirementsRegulatory RequirementsA.A. NIH/NSF Objectivity in ResearchNIH/NSF Objectivity in Research

1.1. To Whom Requirements ApplyTo Whom Requirements Applya)a) InstitutionInstitution

i.i. Written enforced policies on COIWritten enforced policies on COIii.ii. Designated institutional official to review COIDesignated institutional official to review COIiii.iii. Require that each investigator submits a Require that each investigator submits a

disclosure form for PHS and NSF research disclosure form for PHS and NSF research annuallyannually

iv.iv. Provide guidelines to review and manage COIProvide guidelines to review and manage COIv.v. Maintain records for 3 yearsMaintain records for 3 yearsvi.vi. Establish enforcement mechanisms and sanctionsEstablish enforcement mechanisms and sanctionsvii.vii. Report failures to comply to awarding agencyReport failures to comply to awarding agency

Sample Program Effectiveness Sample Program Effectiveness Targets (con’t)Targets (con’t)

b)b) InvestigatorInvestigator

i.i. Must disclose any “significant financial interests” Must disclose any “significant financial interests” (including those of spouse and dependent (including those of spouse and dependent children) that would reasonably appear to be children) that would reasonably appear to be affected by the research to a designated affected by the research to a designated institutional official by the time the application is institutional official by the time the application is submitted to PHS/NSF.submitted to PHS/NSF.

2.2. In what activities?In what activities?1.1. ResearchResearch

Sample Program Effectiveness Sample Program Effectiveness Targets (con’t)Targets (con’t)

II.II. Industry Standards Industry Standards A.A. IRB AAHRPP Accreditation StandardsIRB AAHRPP Accreditation Standards

B.B. AAMC Guidance, “Individual Financial AAMC Guidance, “Individual Financial Conflicts in Research” (2001, 2004)Conflicts in Research” (2001, 2004)

C.C. [Name other relevant industry guidance [Name other relevant industry guidance documents] documents]

D.D. Peer Institution BenchmarksPeer Institution Benchmarks1.1. [name specific institutions][name specific institutions]

Sample Program Effectiveness Sample Program Effectiveness Targets (con’t)Targets (con’t)

III.III. Best Practices TargetsBest Practices TargetsA.A. User friendly, effective policiesUser friendly, effective policies

i.i. Not text heavy, minimum verbiage-- “Just tell Not text heavy, minimum verbiage-- “Just tell me what I need to do”.me what I need to do”.

ii.ii. Define scope, audience and other parametersDefine scope, audience and other parameters

iii.iii. Identify “the rule”Identify “the rule”

iv.iv. Contact infoContact info

v.v. Step by step instructionsStep by step instructions

vi.vi. Generous white spaceGenerous white space

vii.vii. Flexible, modular outlineFlexible, modular outline

Sample Program Effectiveness Sample Program Effectiveness Targets (con’t)Targets (con’t)

B.B. User friendly access to informationUser friendly access to informationi.i. Info is accessible via easily navigable webpageInfo is accessible via easily navigable webpage

C.C. Effective disclosure monitoringEffective disclosure monitoring

D.D. Effective education and training on Effective education and training on proceduresprocedures

1.1. Existing employeesExisting employees

2.2. New employeesNew employees

E.E. Monitoring complianceMonitoring compliance

F.F. Consistency of treatment Consistency of treatment

HOMEWORKHOMEWORK

Use the Use the Sample Program EvaluationSample Program Evaluation as a as a model to describe your own COI Unit and model to describe your own COI Unit and the regulatory/standards/best practices the regulatory/standards/best practices that apply to your programthat apply to your program

Send me the completed template by Send me the completed template by Monday, Monday, January 7, 2008.January 7, 2008.

Call on me for help with any aspect of the Call on me for help with any aspect of the Program Evaluation—I am here to assist Program Evaluation—I am here to assist you you cmcwhirt@health.usf.educmcwhirt@health.usf.edu or 974-6676 or 974-6676